Dupixent's on a roll in eczema and asthma, but COPD's a ‘much tougher’ malady

Armed with new nods in asthma and adolescent eczema, Regeneron’s Dupixent keeps reeling in new biologics patients. But as phase 3 results in COPD loom, helmsman Len Schleifer warns that tapping into that disease could be "much tougher."

First-quarter Dupixent sales, registered by Regeneron partner Sanofi, beat analyst estimates as the U.S. alone hit $303 million. And total prescriptions jumped 18% sequentially, Regeneron SVP Marion McCourt said on a conference call with analysts.

That growth depends in part on expanding the market for biologics in asthma patients, thanks to an FDA nod last October. Since that launch, total biologics scripts for the disease rose over 10%. About three-fourths of Dupixent’s asthma patients are new to biologics, and "a significant opportunity remains for subsequent growth," according to McCourt. Meanwhile, a geographic boost could be on its way, thanks to official EU approvals in asthma unveiled Tuesday.

Regeneron and Sanofi have called Dupixent a pipeline in a drug for its promise in treating multiple Type 2 inflammatory diseases. Clinical data and even real-world experience are piling up to show the dual IL-4 and IL-13 inhibitor can offer relief for patients who suffer several inflammatory maladies at the same time, Regeneron president and chief scientific officer George Yancopoulos said on the Q1 call. For example, in its adolescent eczema trials—which supported an FDA approval in March—more than 90% of participants had at least one other allergic condition, and more than 15% suffered from asthma along with eczema, he said.

But COPD is different, and Schleifer said Regeneron doesn't have a "high degree of confidence" in Dupixent's ability to conquer that disease.

Researchers saw "clear-cut effects" in Dupixent's asthma studies, but "COPD is much tougher," Schleifer said. Regeneron's not giving up on the indication, "but we wouldn’t rank this as something we have high degree of confidence in," he said.

"COPD is a very complex disease," echoed Yancopoulos. Many patients who have COPDs worsened with other Type 2 inflammations, and "the problem is finding the right patients to treat, and also negotiating with the FDA who likes to study cleaner diseases," he explained.

COPD is indeed a tough nut to crack, previous studies have shown. Dupixent's biologics competitors, GlaxoSmithKline's Nucala and AstraZeneca's Fasenra, have both turned up failure in the field.

Aside from Dupixent, Regeneron's eye injection Eylea continues to deliver in its eighth year on the market, as U.S. sales grew 9% year over year to $1.07 billion. Even more could be coming for the Bayer-partnered med: In what McCourt called the anti-VEGF drug’s "largest growth opportunity," the company is awaiting an FDA decision in diabetic retinopathy. And the company in April refiled an application for a pre-filled syringe, which the agency had rebuffed on lack of information on its manufacturing and supply processes.

Meanwhile, its Sanof-partnered PD-1 med Libtayo, which has gained a foothold in cutaneous squamous cell carcinoma, posted its second straight beat against analyst estimates, with first-quarter sales of $27 million, Piper Jaffray analyst Christopher Raymond noted in a Tuesday report. Regeneron and Sanofi have big hopes for moving beyond that niche market, too; they're eyeing the lucrative first-line lung cancer that’s now dominated by Merck & Co.’s Keytruda.

Good news aside, PCSK9 drug Praluent missed expectations, as volume growth couldn’t offset pricing pressure. But the drug a few days ago snagged a label expansion to include its cardiovascular benefits and with it a better chance at fighting Amgen’s Repatha.

All told, Regeneron’s Q1 revenue of $1.71 billion fell short of Street estimates of $1.77 billion, though much of that shortfall was caused by lower-than-expected Sanofi collaboration revenue and won’t affect Regeneron’s bottom line, Raymond said.

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